NCT02661620

REDAPT Retrospective-Prospective Modular Stem Study

A Retrospective-Prospective Study of REDAPT™ Revision Femoral System Modular Stem

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 140 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

A Retrospective-Prospective Study of REDAPT Revision Femoral System Modular Stem is a post-market, retrospective-prospective, multi-center, single arm, consecutive series study design to provide data on the post market performance and safety of the study device. The study will collect retrospective data from medical records review and prospective data from observations data at 5 and 10 postoperatively clinical visits. There will also be a 7.5 year telephone follow up contact to assess for device status and adverse events.

Detailed description

The primary purpose of this study is to demonstrate the REDAPT™ Revision Femoral System modular stem cumulative revision rate at 5 years. The secondary purpose of this study is to provide 10 years of safety and performance data on the REDAPT™ Revision Femoral System modular stem in terms of Standard of Care Radiographic Assessment, Harris Hip Sore (if obtained prior to implant), adverse event assessment, whole blood metal ion level assessment for Cobalt and Chromium (only performed if subject if symptomatic with pain, swelling, and/or functional limitation related to the device and/ implant procedure as assessed by the Principal Investigator (PI), and Metal artifact reduction sequence (MARS) magnetic resonance imaging (MRI) or Computed Tomography (CT) will be obtained if metal ion levels of Cobalt and/or Chromium \> 7parts per billion (ppb) 140 subjects have been enrolled in the study at 5 clinical study sites around the world. A Clinical Study Report (CSR) will be completed at years 5 and 10.

Conditions

• Arthroplasties, Hip Replacement

Interventions

Type	Name	Description
DEVICE	REDAPT Revision Femoral System modular stem	Medical record review for retrospective information and observational prospective data collection of standard of care items at 5 years and 10 years post operatively plus a 7.5 year post op telephone call to assess stem status and adverse events.

Timeline

• Start date: 2016-02-01
• Primary completion: 2020-04-16
• Completion: 2020-04-16
• First posted: 2016-01-22
• Last updated: 2024-04-02

Locations

5 sites across 3 countries: United States, Belgium, Canada